Vancomycin 250mg Capsules

Manufacturer CAMERON PHARMACEUTICALS Active Ingredient Vancomycin Capsules(van koe MYE sin) Pronunciation van koe MYE sin
It is used to treat certain types of bowel infections. This includes an infection called C diff.
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Drug Class
Glycopeptide antibiotic
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Pharmacologic Class
Cell wall synthesis inhibitor
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Pregnancy Category
B
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FDA Approved
Mar 1986
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Vancomycin capsules are an antibiotic used to treat a severe type of diarrhea caused by a specific germ called Clostridioides difficile (C. diff). Unlike other antibiotics that get absorbed into your body, this medicine stays mostly in your intestines to kill the C. diff bacteria there.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety of your medication, store it at room temperature in a dry location, avoiding bathrooms. Keep all medications in a secure place, out of the reach of children and pets. Properly dispose of any unused or expired medication. Unless instructed to do so by your doctor or pharmacist, do not flush medication down the toilet or pour it down the drain. If you have questions about disposing of your medication, consult your pharmacist, who can also inform you about potential drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take the medicine exactly as prescribed, even if you start feeling better.
  • Do not skip doses or stop taking it early, as this can lead to the infection coming back.
  • Maintain good hydration, especially if you have severe diarrhea.
  • Practice good hand hygiene (wash hands frequently with soap and water) to prevent spread of C. diff.
  • Avoid alcohol while taking this medication.

Dosing & Administration

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Adult Dosing

Standard Dose: 125 mg orally 4 times daily for 10 days
Dose Range: 125 - 500 mg

Condition-Specific Dosing:

Clostridioides difficile-associated diarrhea (CDAD): 125 mg orally 4 times daily for 10 days
Severe/Fulminant CDAD: 500 mg orally 4 times daily for 10-14 days, often with IV metronidazole
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Pediatric Dosing

Neonatal: Not established for oral use in neonates for CDI. IV vancomycin is used for systemic infections.
Infant: 10 mg/kg orally 3-4 times daily for 10 days (max 500 mg/dose) for CDI.
Child: 10 mg/kg orally 3-4 times daily for 10 days (max 500 mg/dose) for CDI.
Adolescent: 125 mg orally 4 times daily for 10 days for CDI (same as adult dose).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No adjustment needed (minimal systemic absorption; not removed by dialysis from GI tract)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Vancomycin is a tricyclic glycopeptide antibiotic that inhibits bacterial cell wall synthesis by binding with high affinity to the D-Ala-D-Ala terminus of the peptidoglycan precursor units. This binding prevents the transglycosylation and transpeptidation steps, leading to defective cell wall formation and increased bacterial cell membrane permeability, ultimately resulting in bacterial cell lysis and death. It is bactericidal against susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: <5% (systemic absorption from oral administration)
Tmax: Not applicable for systemic effect; acts locally in GI tract
FoodEffect: Minimal effect on local action in GI tract; can be taken with or without food.

Distribution:

Vd: Not applicable for oral use (minimal systemic distribution)
ProteinBinding: Not applicable for oral use (minimal systemic absorption)
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not applicable for oral use (minimal systemic absorption)
Clearance: Not applicable for oral use (minimal systemic absorption)
ExcretionRoute: Primarily excreted unchanged in feces (90-95% of oral dose)
Unchanged: >90% (in feces)
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Pharmacodynamics

OnsetOfAction: Clinical improvement typically within 2-4 days for CDI
PeakEffect: Not applicable for systemic effect; local action in GI tract
DurationOfAction: Maintained throughout dosing interval due to local gut concentrations

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or significant weight gain.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Swelling in the arms or legs.
Hearing loss or changes in hearing, which may be permanent and more likely with long-term use. Do not take this medication for longer than prescribed by your doctor.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening and may also affect internal organs. Seek medical help immediately if you experience: red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor:

Diarrhea, stomach pain, upset stomach, or vomiting.
Gas.
Feeling tired or weak.
Back pain.
Headache.

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Diarrhea that gets worse or does not improve after a few days
  • Severe stomach pain or cramping
  • Fever that does not go away
  • Signs of dehydration (very dry mouth, decreased urination, dizziness)
  • New or worsening rash, hives, or itching
  • Difficulty breathing or swelling of the face/throat (signs of severe allergic reaction - seek immediate medical attention)
  • Ringing in the ears or hearing loss (rare, but report if occurs)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken safely with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you have a history of kidney problems, such as kidney failure, notify your doctor, as this medication can cause kidney issues.

Regular blood work and other laboratory tests, as directed by your doctor, are crucial to monitor your health while taking this drug.

You may require periodic hearing tests during treatment with this medication; consult with your doctor to discuss the necessity of these tests.

Do not exceed the prescribed duration of treatment, as prolonged use can lead to a secondary infection.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Due to very poor systemic absorption, overdose with oral vancomycin is unlikely to cause systemic toxicity (like kidney damage or hearing loss).
  • Possible symptoms might include severe gastrointestinal upset (nausea, vomiting, diarrhea).

What to Do:

Contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.

Drug Interactions

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Moderate Interactions

  • Cholestyramine (may bind vancomycin and reduce its efficacy in the gut; separate administration by several hours)
  • Other nephrotoxic or ototoxic drugs (theoretical risk, but very low due to minimal systemic absorption of oral vancomycin)

Monitoring

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Baseline Monitoring

Diagnosis of Clostridioides difficile infection (CDI)

Rationale: Confirm appropriate indication for oral vancomycin

Timing: Prior to initiation

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Routine Monitoring

Clinical response (resolution of diarrhea, fever, abdominal pain)

Frequency: Daily

Target: Improvement of symptoms

Action Threshold: Lack of improvement or worsening symptoms after 3-5 days may indicate need for re-evaluation or alternative therapy

Fluid and electrolyte balance

Frequency: As clinically indicated, especially in severe diarrhea

Target: Normal hydration and electrolyte levels

Action Threshold: Signs of dehydration or electrolyte imbalance (e.g., hypokalemia, hyponatremia) require intervention

Renal function (BUN, creatinine)

Frequency: Not routinely required due to minimal systemic absorption; consider if prolonged use or underlying renal impairment

Target: Within normal limits

Action Threshold: Significant increase in creatinine (rare with oral vancomycin) may warrant investigation

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Symptom Monitoring

  • Persistent or worsening diarrhea
  • Fever
  • Abdominal pain or tenderness
  • Signs of dehydration (decreased urination, dry mouth, dizziness)
  • Rash or itching (possible allergic reaction)
  • Hearing changes or ringing in ears (ototoxicity, very rare with oral vancomycin)
  • Changes in urination (nephrotoxicity, very rare with oral vancomycin)

Special Patient Groups

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Pregnancy

Generally considered safe for use during pregnancy for CDI due to minimal systemic absorption. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Considered compatible with breastfeeding for CDI. Minimal amounts are absorbed systemically and even less are expected to pass into breast milk. Infant exposure is very low, and any absorbed by the infant would also be poorly absorbed from their GI tract.

Infant Risk: Low risk (L3)
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Pediatric Use

Effective and generally safe for treating CDI in pediatric patients. Dosing is weight-based. Close monitoring for clinical response is important.

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Geriatric Use

No specific dose adjustment needed based on age alone for CDI, due to minimal systemic absorption. However, elderly patients may be more susceptible to dehydration from severe diarrhea and should be monitored closely for fluid and electrolyte balance.

Clinical Information

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Clinical Pearls

  • Oral vancomycin is primarily used for the treatment of Clostridioides difficile infection (CDI) because it is poorly absorbed from the gastrointestinal tract, allowing it to act locally in the colon.
  • It is NOT used for systemic infections (e.g., MRSA bacteremia, pneumonia) as it does not achieve therapeutic systemic concentrations when given orally.
  • Therapeutic drug monitoring (TDM) of vancomycin serum levels is NOT indicated for oral vancomycin therapy for CDI.
  • Systemic adverse effects like nephrotoxicity, ototoxicity, and 'red man syndrome' are extremely rare with oral vancomycin due to minimal systemic absorption.
  • For severe or fulminant CDI, oral vancomycin is often used in combination with intravenous metronidazole.
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Alternative Therapies

  • Fidaxomicin (another oral antibiotic for CDI)
  • Metronidazole (oral, for initial non-severe CDI)
  • Bezlotoxumab (monoclonal antibody for prevention of CDI recurrence)
  • Fecal microbiota transplantation (FMT) (for recurrent CDI)
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Cost & Coverage

Average Cost: Varies widely, e.g., $500 - $2000+ per 20 capsules (125mg)
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization for CDI)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.